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Completed

NCT Number: NCT07814625

Improving the Outcomes of Nasoalveolar Molding in Complete Bilateral Cleft Lip and Palate Neonates Using a Modification in the Design of the Conventional Molding Appliance.

The goal of this clinical trial was to improve the outcome of using the nasoalveoalr molding appliances in patients with complete bilateral cleft lip and palate.

The primary outcome was to compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior, transverse, and vertical. The changes in the maxillary arch were assessed via the digital models acquired at two time intervals: before NAM therapy and 4 months after the start of either intervention modality (VMA and CMA).

Participants were divided into two groups: the vomer molding appliance group and the conventional molding appliance group , the appliances were delivered , followed up for 4 months till primary cheiloplasty and the results were assessd before the surgert.

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Key information

Conditions

Cleft Lip and Cleft Palate Cleft Lip Cleft Lip Bilateral Cleft Palate Complete Bilateral Cleft Lip and Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

1 day–15 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry -Tanta university

Tanta, Gharbia Governorate, 11311, Egypt

About this study

Before the commencement of NAM therapy, an impression of the infant's maxillary arch was taken using a additional silicone elastomeric impression material (regular viscosity). The procedure involved a customized acrylic tray and was conducted with the infant fully awake, positioned head facing the clinician, and securely held by an assistant in the clinic. The impression should record accurately all the maxillary arch extending to the labial vestibule anteriorly and to the maxillary tuberosity posteriorly and registering all the undercuts around the vomer. The impression poured in hard stone , wax pattern made on the master cast , flasking and curing with clear heat cure acrylic resin and finishing and polishing before delivering to the baby.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-syndromic complete bilateral cleft lip and palate neonate.
  • The deviation of the premaxilla is to the right side for ease of comparison.

Exclusion criteria

  • Syndromic cases.
  • Patients who received former interventions.

Treatment and study plan

vomer molding appliance

Device

All the infants in the VMA group received clear heat cured acrylic resin appliance. Firstly, an impression was taken using additional rubber base (Zhirmach-Germany) and registering all undercuts carefully then impression was poured using Type III stone maintaining the desired undercuts around the vomer. Wax pattern of the appliance was made, with two retentive arms flasking, packing with clear heat cured acrylic resin then curing, finishing and polishing.

conventional molding appliance

Device

After taking the impression and pouring the cast, it was prepared by blocking out all undercut areas with stone or plaster. An intraoral molding plate was then fabricated on the prepared working model using clear heat-cured acrylic resin. Retention of the appliance in both groups was achieved in the same manner; medium elastic bands (3/16 inch, 4.5 oz) were looped around each button and secured to the cheeks with surgical tape. The elastic bands were stretched to twice their passive diameter to ensure proper force activation and retention. Protective tape was applied to the cheeks to minimize tissue irritation from the surgical tapes, and further emollient creams were prescribed when needed. Additionally, horizontal lip tape was applied across the base of the nose, extending from one cheek to the other, starting from the first visit with the same-sized elastic band in the middle.

Primary outcomes

  1. Compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior, transverse, and vertical.

    Time frame: from enrollment till 4 months of age

    The changes in the maxillary arch were assessed via the digital models acquired at two time intervals: before NAM therapy and 4 months after the start of either intervention modality (VMA and CMA).

  2. Compare VMA and CMA regarding the three-dimensional change in the maxillary arch: anteroposterior & transverse.

    Time frame: from enrollment to the end of treatment before primary chieloplasty (about 4 months of age)

    The changes in the maxillary arch were assessed via the digital models acquired at two time intervals: before NAM therapy and 4 months after the start of either intervention modality (VMA and CMA).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Improving the Outcomes of Nasoalveolar Molding in Complete Bilateral Cleft Lip and Palate Neonates: Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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